Evidence map›Paper›PMID 40001655›Full record

ReviewBioengineering (Basel, Switzerland)2025

Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices.

Elena V A van Hengel, Luc J W van der Laan, Jeroen de Jonge, Monique M A Verstegen

Abstract readReview
In one paragraph

Review in Bioengineering (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Elena V A van HengelDepartment of Surgery, Erasmus MC Transplant Institute, University Medical Center Rotterdam, 3015 GD Rotterdam, The Netherlands.
Luc J W van der LaanDepartment of Surgery, Erasmus MC Transplant Institute, University Medical Center Rotterdam, 3015 GD Rotterdam, The Netherlands.ORCID 0000-0002-0651-5334
Jeroen de JongeDepartment of Surgery, Erasmus MC Transplant Institute, University Medical Center Rotterdam, 3015 GD Rotterdam, The Netherlands.
Monique M A VerstegenDepartment of Surgery, Erasmus MC Transplant Institute, University Medical Center Rotterdam, 3015 GD Rotterdam, The Netherlands.ORCID 0000-0001-9908-6673

Funding

Topconsortium Kennis en Innovatie-Life Sciences & Health EMC-LSH19002
6 · The paper itself

Abstract

Whole-organ decellularization generates scaffolds containing native extracellular matrix (ECM) components with preserved tissue microarchitecture, providing a promising advancement in tissue engineering and regenerative medicine. Decellularization retains the ECM integrity which is important for supporting cell attachment, growth, differentiation, and biological function. Although there are consensus guidelines to standardize decellularization processes and ECM characterization, no specific criteria or standards regarding matrix sterility and biosafety have been established so far. This regulatory gap in safety, sterilization, and regulation criteria has hampered the clinical translation of decellularized scaffolds. In this review, we identify essential criteria for the safe clinical use of decellularized products from both human and animal sources. These include the decellularization efficacy, levels of chemical residue, preservation of ECM composition and physical characteristics, and criteria for the aseptic processing of decellularization to assure sterility. Furthermore, we explore key considerations for advancing decellularized scaffolds into clinical practice, focusing on regulatory frameworks and safety requirements. Addressing these challenges is crucial for minimizing risks of adverse reactions or infection transmission, thereby accelerating the adoption of tissue-engineered products. This review aims to provide a foundation for establishing robust guidelines, supporting the safe and effective integration of decellularized scaffolds into regenerative medicine applications.

Indexed as

advanced therapy medicinal productdecellularizationextracellular matrixmedical deviceregenerative medicineregulationstissue engineering

Identifiers

PMID40001655
PMCPMC11851377

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.